The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

Device Description

The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI-powered device.

Instead, the document is a 510(k) premarket notification summary for two tracheal intubation fiberscopes/videoscopes (OLYMPUS LF-P and VISERA LF Type V). This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and non-clinical bench testing, rather than a clinical study of an AI device meeting specific performance criteria.

Therefore, I cannot provide the requested information from the given input.

Summary

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September 26, 2022

Olympus Medical Systems Corp. % Brenda Geary Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581

Re: K221631

Trade/Device Name: Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 19, 2022 Received: August 19, 2022

Dear Brenda Geary:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221631

Device Name

Tracheal Intubation Fiberscope OLYMPUS LF-P VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in blue, with a registered trademark symbol next to it. Below the word is a yellow and orange graphic. To the right of the word "OLYMPUS" is the alphanumeric code "K221631".

Date Prepared: June 3, 2022

510(k) Summary

A. SPONSOR INFORMATION

510(k) Submitter:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi,Tokyo, Japan 192-8507
Official Correspondent:	Brenda GearyOlympus Corporation of the Americas800 West Park DriveWestborough, MA 01581Cell: (928) 707-2852Email: brenda.geary@olympus.com

Official Correspondent: Brenda Geary

B. DEVICE IDENTIFICATION

■ Device Name(s):	TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-PVISERA TRACHEAL INTUBATION VIDEOSCOPEOLYMPUS LF TYPE V
■ Model Name(s):	OLYMPUS LF-P, OLYMPUS LF-V
■ Common Name:	Tracheal Intubation Videoscope
■ Regulation Number:	874.4680
■ Regulation Name:	Bronchoscope (flexible or rigid) and accessories
■ Regulatory Class:	II
■ Product Code:	EOQ: Bronchoscope (Flexible or Rigid)
■ Classification Panel:	Division of Dental and ENT Devices (DHT1B)

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C. PREDICATE DEVICES

1 Predicate device for LF-P

Device Name	510(k) Submitter	510(k) No.
PREDICATE
OLYMPUS LF-TP AND LF-DP Tracheal IntubationFiberscopes, Accessories and Ancillary Equipment	Olympus Optical Co.,Ltd.	K981543

Predicate devices for LF-V .

Device Name	510(k) Submitter	510(k) No.
PREDICATE
OLYMPUS LF-TP AND LF-DP Tracheal IntubationFiberscopes, Accessories and Ancillary Equipment	Olympus Optical Co.,Ltd.	K981543
REFERENCE PREDICATE
Tracheal Intubation Fibervideoscope LF-Y0004 and LF-Y0005	Olympus MedicalSystems Corp.	K082720

D. DEVICE DESCRIPTION

LF-P Device Description

LF-V Device Description

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E. INDICATIONS FOR USE

LF-P Indications for Use

LF-V Indications for Use

F. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE

	SUBJECT DEVICE:LF-P Tracheal Intubation Fiberscope	PRIMARY PREDICATE:LF-DP Tracheal Intubation Fiberscopes(K981543)
Manufacturer	Olympus Medical	SAME
Classification& RegulationNumber	Class II21 CFR §874.4680	SAME
Product Code	EOQ - Bronchoscope (Flexible or Rigid)	SAME
Intended Use	The TRACHEAL INTUBATIONFIBERSCOPE OLYMPUS LF-P has beendesigned to be used with an Olympus videosystem center, documentation equipment,display monitor and other ancillary equipmentfor airway management, which includesendoscopic observation to access airwayanatomy, endotracheal/endobronchialintubation and management.	These instruments have been designed to beused with a Suction Pump and other ancillaryequipment for airway management, whichincludes observation to access airway anatomy,endotracheal/endobronchial intubation andmanagement. Do not use these instruments forany purpose other than their intended use.
Field of View	75°	90°
Direction ofView	0° (Forward viewing)	SAME
Depth ofField	2-50mm	3-50mm
OptimumWorkingDistance	7.0mm	6.0mm
InsertionTubeDiameter	Distal end size: ø 1.8mmFlexible tube outer Diameter: ø 2.2mm	Distal end size: ø 3.1mmFlexible tube outer Diameter: ø 3.1mm
Insertionsection	600mm	SAME

LF-P Tracheal Intubation Fiberscope

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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A thin, horizontal yellow line is located beneath the word. The registered trademark symbol is located to the right of the word.

	SUBJECT DEVICE:LF-P Tracheal Intubation Fiberscope	PRIMARY PREDICATE:LF-DP Tracheal Intubation Fiberscopes(K981543)
WorkingLength
AngulationRange	Up 120° / Down 120°	SAME
Light Guide(LG) CableConfiguration	Not detachable	Detachable

LF-V Tracheal Intubation Videoscope

	SUBJECT DEVICE:LF-V Tracheal IntubationVideoscope	PRIMARY PREDICATE:LF-DP TrachealIntubation Fiberscopes(K981543)	REFERENCE PREDICATE:LF-Y0004 Tracheal IntubationFibervideoscope (K082720)
Manufacturer	Olympus Medical	Olympus Medical	Olympus Medical
Classification& RegulationNumber	Class II21 CFR §874.4680	SAME	SAME
Product Code	EOQ - Bronchoscope(Flexible or Rigid)	SAME	SAME
Intended Use	The VISERA TRACHEALINTUBATIONVIDEOSCOPE OLYMPUSLF TYPE V has beendesigned to be used with avideo system center, lightsource, documentationequipment, display monitor,suction pump, and otherancillary equipment forairway management whichincludes endoscopicobservation to access airwayanatomy,endotracheal/endobronchialintubation and management.	These instruments havebeen designed to be usedwith a Suction Pump andother ancillary equipmentfor airway management,which includes observationto access airway anatomy,endotracheal/endobronchialintubation and management.Do not use theseinstruments for any purposeother than their intendeduse.	These instruments have beendesigned to be used with aSuction Pump andEndoTherapy accessories andother ancillary equipment forairway management, whichincludes endoscopic treatment,diagnosis, and observation toaccess airway anatomy,endotracheal/endobronchialintubation and management.
Field of View	120°	90°	90°
Direction ofView	0° (Forward viewing)	SAME	SAME
Depth of Field	3-50mm	SAME	4-50 mm
OptimumWorkingDistance	9.0mm	6.0mm	9.5mm
InsertionTubeDiameter	Distal end size: ø 3.8mmFlexible tube outerDiameter: ø 4.1mm	Distal end size: ø 3.1mmFlexible tube outerDiameter: ø 3.1mm	Distal end size: ø 3.9mmFlexible tube outer Diameter: ø4.1mm
InsertionsectionWorkingLength	600mm	SAME	SAME

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Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are closely spaced together. There is a yellow gradient line underneath the word. The registered trademark symbol is located to the right of the letter "S".

	SUBJECT DEVICE:LF-V Tracheal IntubationVideoscope	PRIMARY PREDICATE:LF-DP TrachealIntubation Fiberscopes(K981543)	REFERENCE PREDICATE:LF-Y0004 Tracheal IntubationFibervideoscope (K082720)
AngulationRange	Up 120° / Down 120°	SAME	SAME
Light Guide(LG) CableConfiguration	Not detachable	Detachable	None

G. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

General
- ISO 14971 (Medical devices Application of risk management to medical I devices)
Non-Clinical Bench Testing ●

Electrical Testing:

IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
트 IEC 60601-1-2 (Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests)
I IEC 60601-2-18 (Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment)
IEC 62471 (Photobiological safety of lamps and lamp systems)

Performance Testing:

I ISO 8600 (Endoscopes - Medical endoscopes and endotherapy devices, Part 1: General requirements)
Composite durability
I Color performance
트 Image intensity uniformity (IIU)
Field of View and Direction of View
트 Resolution

Reprocessing:

FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Biocompatibility ●
- ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and 트 testing within a risk management process)
- I ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- 트 ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for skin

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Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. Below the word, there is a thin, horizontal, gold bar. The logo is simple and clean, with a focus on the company name.

sensitization)

Clinical Performance Data .

Clinical and animal testing were not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.

H. CONCLUSION

In summary the LF-P and LF-V are substantially equivalent to the predicate devices and present no new questions of safety or effectiveness.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.